Inhibitex Reports Initiation of Multiple Ascending Dose Trial of FV-100 for Shingles
August 06 2008 - 8:30AM
Business Wire
Inhibitex, Inc. (NASDAQ: INHX), a biopharmaceutical company focused
on the development of products to treat serious infectious
diseases, announced today that it has completed a Phase I single
ascending dose (SAD) clinical trial and initiated a multiple
ascending dose (MAD) trial of FV-100, a highly potent and
fast-acting compound being developed to treat shingles (herpes
zoster). The double-blind, placebo-controlled SAD trial evaluated
the safety and pharmacokinetics of four doses of FV-100 in five
cohorts of healthy volunteers (100, 200, 400, and 800 mg, as well
as a 400 mg food effect group). Each cohort consisted of six
subjects that received FV-100 and two that received placebo. The
Company reported that there were no serious adverse events observed
and the compound appeared to be generally well tolerated in the
trial. In addition, pharmacokinetic data demonstrated that all
doses evaluated in the trial maintained drug plasma levels of the
active form of FV-100 that exceeded its EC50 for at least 24 hours.
The EC50 represents the concentration of a drug that is required
for 50% inhibition of viral replication in vitro. The Company plans
to present the full data from the SAD trial at the Interscience
Conference on Antimicrobial Agents and Chemotherapy (�ICAAC�) this
fall. �We are very encouraged by the emerging safety and
pharmacokinetic profile of FV-100 in man,� stated Russell H. Plumb,
president and chief executive officer of Inhibitex. �Subject to the
results of the multiple ascending dose trial, we plan to advance
FV-100 into a well powered, proof of concept Phase II clinical
trial around the end of 2008 to evaluate both once- and twice-daily
doses in shingles patients.� The recently initiated MAD trial in
healthy subjects is designed to evaluate the safety and
pharmacokinetics of five oral doses of FV-100 (100, 200, 400 and
800 mg administered once daily and 200 mg administered twice daily,
each for seven days). Similar to the SAD trial, each dose cohort
will consist of six subjects that will receive FV-100 and two that
will receive placebo. The Company anticipates completing the MAD
trial in the fourth quarter of 2008. About Shingles Shingles, also
know as herpes zoster, is an infection caused by the reactivation
of varicella zoster virus (VZV), the same virus that causes chicken
pox. Worldwide, there are an estimated 2.5 million cases of
shingles each year. Shingles is generally characterized by skin
lesions, rash, acute pain, and in many cases post herpetic
neuralgia (PHN), a painful and sometimes debilitating condition
resulting from nerve damage caused by VZV that can last for several
months or more. While shingles can develop in adults of any age, it
occurs most frequently among those who are 40 and older. About
FV-100 Published in vitro studies have demonstrated that FV-100, a
bicylcic nucleoside analogue, is more potent against and can
inhibit the replication of VZV substantially faster than other
antiviral therapeutics currently approved for the treatment of
shingles. Inhibitex believes these characteristics provide the
potential for FV-100 to reduce the incidence and severity of
shingles-related symptoms, including acute pain and PHN. About
Inhibitex Inhibitex, Inc., headquartered in Alpharetta, Georgia, is
a biopharmaceutical company focused on developing products to treat
and prevent serious infectious diseases. In addition to FV-100, the
Company�s development pipeline includes a series of HCV nucleoside
polymerase inhibitors and HIV integrase inhibitors. Inhibitex has
also licensed its proprietary MSCRAMM� protein technology to Wyeth
for the development of staphylococcal vaccines and to 3M for the
development of diagnostics. For additional information about the
Company, please visit www.inhibitex.com. Safe Harbor Statement This
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that involve substantial risks and uncertainties. All statements,
other than statements of historical facts, including those related
to the potential for FV-100 to be dosed once-a-day and to further
reduce the incidence and severity of shingles-related symptoms,
including the incidence and severity of acute pain and PHN; the
Company�s plan to complete the Phase I MAD trial in the fourth
quarter; the Company�s plan to initiate a Phase II clinical trial
of FV-100 in shingles patients around the end of 2008; and the
Company�s plans to present the full data from the Phase I SAD trial
at ICAAC in the fall are forward-looking statements. These plans,
intentions, expectations, or time estimates may not actually be
achieved and various important factors could cause actual results
or events to differ materially from the forward-looking statements
that the Company makes, including risks that the results of future
preclinical and clinical studies may not confirm prior findings or
support the further development of FV-100; the Company not being
able to enroll patients in its clinical trials in a timely manner;
the Company not obtaining regulatory approval to advance the
development of FV-100; either the Company, the U.S. Food and Drug
Administration (FDA) or an investigational review board (IRB)
suspending or terminating the clinical development of FV-100 for
safety or other reasons; FV-100 not proving to be efficacious in
reducing shingles-related symptoms in patients in future clinical
trials and other cautionary statements contained elsewhere herein
and in its Annual Report on Form 10-K for the year ended December
31, 2007, as filed with the Securities and Exchange Commission, or
SEC, on March 14, 2008, and its Quarterly Report on Form 10-Q for
the quarter ended March 31, 2008 as filed with the SEC on May 9,
2008. Given these uncertainties, you should not place undue
reliance on these forward-looking statements, which apply only as
of the date of this press release. There may be events in the
future that the Company is unable to predict accurately, or over
which it has no control. The Company's business, financial
condition, results of operations and prospects may change. The
Company may not update these forward-looking statements, even
though its situation may change in the future, unless it has
obligations under the Federal securities laws to update and
disclose material developments related to previously disclosed
information. The Company qualifies all of the information contained
in this press release, and particularly its forward-looking
statements, by these cautionary statements. Inhibitex� and MSCRAMM�
are registered trademarks of Inhibitex, Inc.
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